Kornimate/medical-research-clean huggingface dataset:
metabolomics approach after acute intake of grumixama juice

Conditions: Healthy

Summary: investigate the bioavailability of the main flavonoid, their colonic transformation and untargeted metabolites by an metabolomic approach following acute intake of a grumixama juice by humans.

the grumixama is a sweet and little cherry native of the south and southeast regions of the atlantic forest of brazil rich in phenolic compounds, mainly anthocyanins and ellagitannins. the objective of this study is investigate the bioavailability of the main flavonoid, their colonic transformation and untargeted metabolites by an metabolomic approach following acute intake of a grumixama juice by humans. fifteen healthy subjects consumed grumixama juice at single dose, and urine and plasma samples were collected at different time points over 24 h period. the metabolites were analyzed by lc-esi-msn, lc-q-tof plasma and urine were also analyzed using untargeted metabolomic approach for amino acids and organic acids by gcms.

Eligibility criteria:
inclusion criteria: * not have medical historical of cardiovascular, gastrointestinal, hepatic, renal, thyroid and/or diabetes dysfunction * not be alcohol addicts, not use vitamins and other supplements * not are using any kind of medication which affect the digestion and absorption of food, not be smokers * not are pregnant. exclusion criteria: * have medical historical of cardiovascular, gastrointestinal, hepatic, renal, thyroid and/or diabetes dysfunction * be alcohol addicts, use vitamins and other supplements * are using any kind of medication which affect the digestion and absorption of food, be smokers * are pregnant.

Keywords: grumixama urolithins anthocyanins metabolomic approach ellagitannins subjects
study in patients with asthma

Conditions: Asthma

Summary: the purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control drug.


Eligibility criteria:
inclusion criteria: -require regular use of an inhaled beta-2-selective adrenergic agent exclusion criteria: * active acute or chronic disorders of the respiratory system within one month prior to screening * smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history * recent surgical interventions such as lung lobectomy or resection (\< one year), or cardiothoracic interventions * life-threatening systemic and debilitating diseases.

Keywords: asthma formoterol fumarate foradil
use of ibuprofen and acetaminophen for treatment of acute headache post concussion in children

Conditions: Concussion; Headache

Summary: concussions and headache are a significant problem for children and athletes. while headache generally resolves within 7-10 days; a significant proportion of children, 72-93% experience prolonged headache as a symptom of post concussion syndrome (pcs). the prevailing clinical view is that mild head injuries resolve with little chance of complications. however, the reality is quite different. concussion in children presents with a range of severity and results in both short and long-term physical, cognitive, emotional and behavioural sequelae known as pcs with varying times to resolution. to date there are no specific treatments for headache pain related to concussion. physical and cognitive rest is the mainstay of initial concussion management. the number of children presenting to ed's with a history of concussion and headache is increasing. presently there are no evidence based guidelines available to guide the medical team to effectively and consistently manage their headache. our present standard of care is based on the canchild concussion guidelines outlining the child's return to school and activity. yet, our present standard of treatment is compromised and somewhat counterproductive if we are not treating the child's headache pain. our pilot study ' an open label randomized control pilot study examining treatment of headache in the post-concussive youth' showed that routine administration of oral analgesia improves the child's headache symptoms and helps with school re-entry one week post injury, compared to a standard care group defined as non routine administration of pain medications.

objective post injury concussion and headache are problematic for children after mild traumatic brain injuries. there are no evidence based guidelines for the management of acute post concussive headache. the objectives of this study were to assess the efficacy of routine administration of analgesia on concussion headache and classify headaches using the ihs criteria. method a 4 arm open label pilot rct study was conducted. the treatment arms were: (i) acetaminophen,(ii) ibuprofen, (iii) acetaminophen and ibuprofen and (iv) a standard control group. eight to eighteen year olds presenting to emergency with headache 24-48 hours after their first concussion were recruited consecutively and sequentially randomized. demographic data was collected, headache survey administered and standard concussion education given. headaches were diarized over one week capturing the (i) number of headaches, (ii) headache days,(iii) headache intensity and (iv) return to school.

Eligibility criteria:
inclusion criteria: * diagnosed with a first time concussion * english speaking * presenting to emergency with headache 24-48 hours post concussion * normal glascow coma scale * 8-18 years of age exclusion criteria * postive findings on ct scan * patient with cervical injury * history of multiple concussions * positive neurology
randomized controlled trial comparing traditional pelvic floor rehabilitation to pilates in increasing pelvic muscles strength.

Conditions: Muscle Weakness

Summary: the objective of this randomized controlled trial is to determine whether a standardized pilates exercise program can effectively strengthen pelvic floor muscles when compared with conventional pelvic muscle rehabilitation. urinary incontinence is a widespread problem that affects 10-40% of all ambulatory women and pelvic floor muscle training is an effective treatment for this problem. however, its efficacy is proportionate to the effort expended. even among women who are diligent with pelvic muscle rehabilitation, long term follow-up reveals that benefits are lost in the absence of maintenance exercises. while this intervention is effective, recent studies demonstrate that long term adherence to treatment is low. as compliance appears to be a prerequisite to achieving sustained benefit, finding a method of pelvic muscle strengthening that better lends itself to long term commitment could prove beneficial. the currently popular exercise program, known as pilates (named after founder, joseph pilates) consists of a series of low impact, flexibility and muscle toning exercises. the philosophy centers around developing core strength which includes strengthening the pelvic floor. its use has been described in the us since the 1920s.4 five million americans currently participate, as opposed to five thousand ten years ago.5 given its mainstream popularity, pilates would be an appealing as a therapeutic modality for women experiencing pelvic muscle weakness. currently, there are no studies that assess the efficacy of pilates in increasing pelvic muscle strength.


Eligibility criteria:
inclusion criteria: * women 18 yrs or older exclusion criteria: * pregnancy * no pelvic organ prolapse beyond the hymenal ring. * age or medical condition that make it difficult for patient to tolerate exam or follow verbal instructions. * pacemakers * iuds * vaginal infections or urinary tract infections * medical or physical conditions which exclude the proper performance of pilates.

Keywords: week pelvic floor muscle in females
assessment of the hemodynamic effects of peep according to alveolar recruitment during the ards

Conditions: ARDS, Human; Ventilation Therapy; Complications; Alveolar; Disorder

Summary: the corner stone of the treatment of ards is mechanical ventilation with high levels of positive end-expiratory pressure, also called peep. a high level of peep is recommended and frequently used. but peep can lower cardiac output and contribute to circulatory failure during mechanical ventilation. nevertheless, in theory, the peep-induced pulmonary vascular resistance (pvr) increase could depend on the level of alveolar recruitment, but it has never been proven. thus, the aim of this study is to determine the relation between the high-peep induced pvr and the alveolar recruitment or overdistension.

during acute respiratory distress syndrome (ards) the application of positive end-expiratory pressure (peep) prevents expiratory alveolar collapse. however, it can induce a predominant recruitment effect or, on the contrary, alveolar overdistension. the recruitment/overdistension ratio can be easily assessed using r/i ratio (or recruitment-to-inflation ratio). however, peep is likely to lower cardiac output and contribute to the cardiovascular failure that often occurs in patients with ards. among its hemodynamic effects, peep is likely to increase pulmonary vascular resistance and, thus, right ventricular afterload. in theory, this effect should only occur if peep over-distends the lung volume, compressing the "extra-alveolar" vessels and increasing their resistance. however, this different effect of peep on pulmonary vascular resistance depending on the degree of recruitment or overdistension has never been demonstrated during ards in humans. we retrospectively studied data collected from patients with ards, monitored by pulmonary artery catheter (pac), to eventually find a correlation between the high peep-induced pvr increase and recruitement/overdistension profile.

Eligibility criteria:
inclusion criteria: * ards diagnosed * invasive mechanical ventilation * pulmonary artery catheter already in place * esophagal pressure measure exclusion criteria: * pregnancy * prone position at inclusion * legal protection measures
study to gain more information on how safe and effective jivi works in patients with severe hemophilia a (post-marketing investigation)

Conditions: Hemophilia A

Summary: the goal of this study is to give gather more information on how safe and well jivi works in patients with severe hemophilia a. jivi has been approved by various regulatory agencies, including the fda, health canada, japanese health authority and the european medicinal agency. 25 patients will be enrolled and will stay for 1 to 2 years in this study depending on their treatment frequency. researcher will monitor during the course of the study whether patients are developing antibodies (a protein made by the body in response to the drug) affecting the effectiveness of jivi. in addition information on bleedings and patient's wellbeing will be collected.


Eligibility criteria:
inclusion criteria: * participants must ≥ 18 years of age inclusive, at the time of signing the informed consent. * participants with severe hemophilia a (fviii: c\<1%) * ptps (previously treated patients) (≥150 ed (exposure day)) on prophylaxis treatment before enrollment * participants who are immunocompetent. if human immunodeficiency virus (hiv) positive, cluster of differentiation 4 (cd4)+ lymphocyte count \>200/mm\*3 * participants who are willing to complete an ediary * male participants * capable of giving signed informed consent exclusion criteria: * any other inherited or acquired bleeding disorder in addition to hemophilia a. * platelet count \< 100,000/mm\*3 * creatinine \> 2x upper limit of normal * ast or alt \> 5x upper limit of normal (ast: aspartate aminotransferase; alt: alanine aminotransferase) * the participant has a planned major surgery. * the participant is currently participating in another investigational drug study, or has participated in a clinical study involving an investigational drug within 30 days of signing informed consent or previous treatment in a clinical phase iii study with bay 94-9027 (now marketed as jivi). * current evidence (by central laboratory) or history of inhibitor to fviii with a titer ≥ 0.6 bethesda unit (bu). * known hypersensitivity to the drug substance, excipients, or mouse or hamster protein.
long-term safety follow-up study in the prevention of bronchiolitis obliterans syndrome (bos)

Conditions: Bronchiolitis Obliterans

Summary: the purpose of this study is to evaluate long-term safety of l-csa in prevention of bronchiolitis obliterans syndrome (bos) following lung transplantation (ltx) in patients previously enrolled in phase ii/iii l-csa clinical trial 12011.201.

this is an uncontrolled extension study open only to patients who completed the phase ii/iii core study 12011.201 and volunteered to continue or to cross-over to l-csa inhalation therapy. determination of long-term safety and efficacy outcome over a maximum of three years will be assessed.

Eligibility criteria:
inclusion criteria: 1. patient has completed the l-csa clinical trial 12011.201 2. patient is capable of understanding the purpose and risks of the follow-up study, has been fully informed and has given written informed consent to participate in the study 3. female patients of child bearing potential must test negative on standard urine pregnancy test prior to continuation and must agree to practice effective birth control during the study 4. estimated life expectancy \> 6 months 5. capable of self-administration of medications 6. patient has stable creatinine levels exclusion criteria: 1. patients with ongoing irreversible l-csa related serious adverse events 2. patients with known hypersensitivity for ciclosporin a 3. patient intends to participate in another imp clinical trial other than listed in the inclusion criteria 4. patient receives mechanical ventilation 5. patients underwent pulmonary re-transplantation 6. patient is a pregnant or breast-feeding woman 7. patient is unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol 8. patient receives any systemic or topical rosuvastatin 9. patient has been previously enrolled in this study 10. patient with malignancy diagnosed during study 12011.201 (with the exception of skin cancer) 11. documented respiratory infections unless on appropriate antimicrobial therapy with evidence of clinical response 12. patient is not eligible to continue imp inhalation according to the investigator's discretion

Keywords: inhalation lung transplantation cyclosporine
pathogenesis and genetics of environmental asthma ozone study

Conditions: Asthma; Inflammation

Summary: the goals of the research are designed to accomplish genetic association studies of candidate genes in healthy normal individuals exposed to 0.2 ppm for 2.25 hours with intermittent exercise in order to search for associations between defined genotypes/haplotypes and 3 specific in vivo respiratory endpoints: a) change in fev1 immediately after ozone exposure; b) change nonspecific bronchial reactivity as reflected in the change in methacholine pc20 fev1 24 hours after ozone exposure ; and c) change in lung epithelial integrity as reflected in the clearance halftime of technetium 24 hours after ozone exposure. these studies have been carried forward to take place in 4 phases: i) healthy individuals have been exposed to o3 using our standard exposure protocol; and we will increase the numbers of individuals available for study. ii) perform genetic association studies for the endpoints of spirometry (fev1, fvc, fev1/fvc), pc20 fev1 for methacholine, and epithelial integrity (clearance halftime) for 3 candidate o3 response genes taken from literature searches and/or previously characterized to demonstrate associations. these physiologic endpoints have been examined in terms of both a continuum of response, and discrete "responder" and "non-responder" endpoints.


Eligibility criteria:
inclusion criteria: * subjects with normal lung function values, and of normal body habitus (i.e., \< bmi of 30); * do not have a history of lung disease, and not taking any medications for lung disease or other clinical disorders, and no prior or current smoking history. exclusion criteria: * non-willingness to sign a consent form for participation.

Keywords: ozone inflammatory airway disease polymorphisms
positive emotions program for schizophrenia (peps)

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this study evaluates the addition of a 8 session psychological program, called positive emotions program for schizophrenia (peps) to improve motivation and pleasure in adults with schizophrenia. half of the participants will receive their usual treatment and peps in combination, while the other half will receive usual treatment only.

recent literature has distinguished the negative symptoms associated with a diminished capacity to experience (apathy, anhedonia) from those which are associated with a limited capacity for expression (emotional blunting, alogia). the apathy-anhedonia syndrome tends to be associated with a poorer prognosis than the symptoms related to diminished expression, suggesting that it is the more severe facet of the psychopathology. however the efficacy of drug-based treatments and psychological interventions on primary negative symptoms remains limited. there is a clear clinical need for developing treatments for negative symptoms. the positive emotions programs for schizophrenia (peps) teaches skills to help overcome defeatist thinking and to increase the anticipation and maintenance of positive emotions. peps involves eight one-hour group sessions, administered using visual and audio materials as part of a powerpoint presentation of slides projected onto a screen. the goal of the study is to establish if peps is clinically effective by using a randomized, controlled and assessor-blind trial. a combination of peps plus treatment as usual will be compared to treatment as usual alone. participants diagnosed with a schizophrenia spectrum disorder will undergo either intervention for eight weeks. testing will evaluate individuals' current psychopathology and ability to savor pleasure and will be performed at the time of inclusion, at the end of the eight-week intervention and at six month follow-up.

Eligibility criteria:
inclusion criteria: * a psychotic disorder according to icd 10 (f20 or f25), diagnoses having been established by experienced clinicians; * presenting a score of at least 2 on the overall sans anhedonia scale; * french-speaking; * ability to consent measured with the san diego brief assessment of capacity to consent (ubacc)-a decisional capacity instrument. exclusion criteria: * evidence of organic brain disease, clinically significant concurrent medical ill/ness, or learning disability; * no understanding of the study protocol as assessed with the san diego brief assessment of capacity to consent (ubacc)-a decisional capacity instrument

Keywords: anhedonia apathy negative symptoms anticipatory pleasure savoring
evaluation of advanced us tools in assessing allograft complications

Conditions: Renal Failure; Chronic Kidney Diseases; Failure,Kidney; Renal Artery Stenosis; Fibrosis; Complications

Summary: this study evaluates the role of advanced us technology in assessing renal transplants as screening tools such as 3d ultrasound, ultrasound swe, and mfi besides current ultrasound conventional metheds.

this study will focus on monitoring renal after transplantation using all us advanced technology. aim one will concentrate on the 3d us in assessing artery stenosis (tras) compared to the gold standard. aim two focuses on will concentrate on ultrasound elastography in assessing renal stiffness. aim three will compare us colour modes such as pd, cd and mfi to assess renal perfusion in three groups. duration: 18 months; participants will have a patient information sheet; once they are happy to participate, consent will be obtained. study data will be entered into a database encrypted and stored in the department. only the study principal investigator (pi) will know the study database password.

Eligibility criteria:
inclusion criteria * patients ≥ 18 years. * tx patients. * gender. exclusion criteria * prisoners. * patients \< 18 years. * pregnant women

Keywords: 3d ultrasound us elastography us mfi ultrasound mri ct
communication regarding preclinical dementia diagnostic and diagnostic disclosure among patients with mci and scd

Conditions: Alzheimer Disease; Mild Cognitive Impairment (MCI); Subjective Cognitive Decline (SCD)

Summary: the study investigate what information individuals with scd or mci and their co-participant would like to receive during pre-diagnostic counseling and diagnostic disclosure, and how this information should be conveyed.

improved diagnostic work-up and the introduction of disease-modifying treatment have led to a shift towards earlier diagnosis. however, there are a need for better understanding of how best to communicate about biomarker use, assessment, and results in individuals with subjective cognitive decline (scd) and mild cognitive impairment (mci). objective: the overarching objective of this study is: to understand what information individuals with scd or mci and their co-participant would like to receive during pre-diagnostic counseling and diagnostic disclosure, and how this information should be conveyed. methods: a prospective survey study persons diagnosed with scd or mci and co-participants will be recruited consecutively from the memory clinic, copenhagen university hospital - rigshospitalet (denmark), toulouse university hospital, (france), university medical centre ljubljana (slovenia) and universitair ziekenhuis brussel (belgium) approximately 30 persons and respective co-participants will be included from each hospital over a period of 12 months. each participating person and co-participant will be asked to complete a very brief questionnaire immediately after disclosure of the diagnosis, and another questionnaire 2-6 weeks after the disclosure visit.

Eligibility criteria:
inclusion criteria: * diagnosed with scd or mci * lumbar puncture performed during the diagnostic process * age at or below 80 years * mmse at or above 24 exclusion criteria: * diagnosis of current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis) * current excessive alcohol intake or substance abuse inclusion criteria for the co-participant: * attended the diagnostic disclosure visit together with the individual diagnosed with scd or mci

Keywords: communication biomarkers counseling diagnostic disclosure mci scd
program extension of real life dosing of remicade in austria for crohn's disease (study p04052)(completed)

Conditions: Crohn's Disease

Summary: the current observational program was determined to collect data on the real life dosing regimen of remicade in patients with crohn's disease (cd) in the hospital and non-hospital setting.

this study population was chosen from a non-probability sample

Eligibility criteria:
inclusion criteria: * subjects with active luminal and/or fistulizing cd. exclusion criteria: * per summary of product characteristics.